FDA extends approval time for COPD drug by three months

NEW YORK — Regulators will take a few months longer to review the approval application for a new drug for treating chronic obstructive pulmonary disease, the drug’s developers said Thursday.

Forest Labs and Almirall said the Food and Drug Administration would require a three-month extension to complete its review of their application for aclidinium bromide, a maintenance drug for COPD. The FDA plans to complete its review and decide whether or not to approve the drug in July.

In February, the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 12-2 in favor of recommending the drug’s approval. Advisory committee votes don’t guarantee approval for a drug, but FDA decisions usually are consistent with them.

The Federal Trade Commission testified against the measure, stating that the bill would likely lead to higher healthcare costs due to diminished competition.

"Health plans would be forced to pay higher drug dispensing fees to pharmacists, undermining the plans’ ability to control drug costs … which in turn would lead to higher insurance premiums, or changes in coverage such as increased deductibles or higher co-pays," testified Richard Feinstein, director of the bureau of competition for the FTC. "Although the commission is sympathetic to the difficulties community pharmacies face, the proposed [antitrust] exemption threatens to raise prices to consumers for much-needed medicine, which would have an especially dire impact on seniors," Feinstein said. "It also threatens to increase the cost to employers who provide healthcare insurance to employees and retirees, which may cause those employers to reduce or eliminate benefits. And there is no assurance that the proposed exemption would produce any offsetting higher quality care."

The testimony may prove controversial if the FTC approves the merger between Express Scripts and Medco as early as next week, as many news reports have speculated will happen.

Critics of that merger suggested the PBM created by an Express Scripts/Medco merger would similarly lead to higher insurance premiums and changes in coverage, such as increased deductibles or higher co-pays, threatening to raise prices to consumers for much-needed medicine that would have an especially dire impact on seniors without any assurance that the proposed merger would produce any offsetting higher quality care.

"There are few mergers I’ve ever seen that are as anticompetitive as this meger," David Balto, antitrust attorney and former FTC policy director told reporters Wednesday afternoon during a press conference convened by the Preserve Community Pharmacy Access NOW! coalition — a coalition of pharmacy interests specifically formed in opposition of the proposed Express Scripts/Medco merger. Balto pointed out that as many as 78 Congress members have written the FTC advocating that this merger be disallowed precisely because of its anticompetitive potential. The coalition convened the press conference to call on all state attorneys general to file suit against the ESI/Medco merger should that be approved by the FTC.

Express Scripts early Wednesday filed a Form 8-K with the Securities Exchange Commission that they expect the proposed merger to close as early as next week, suggesting that an FTC decision may be imminent.

According to published reports, attorneys general in New York, Pennsylvania, Ohio, Texas and California already are considering filing suit to block the merger if it is passed without serious conditions.

It is amazing that pharmacies/drugstores only just think that this would have them over a barrel. The situation has been present all along and steadily getting worse but the Corporate owners were too busy counting the money they were making to see the slide in services pharmacists would be able to provide under the payment scheme. Walgreens need to be recognized for their stance on refusing to accept reduced payments (for providing more services) for Express Scipts members.
All chains should let the merger occur and then refuse to accept their contract - all members of the merged beast would have to voice their concerns and pay normal and customary prices (let's all abandon $4 generics!).
Should the Tail be wagging the dog or should the Dog be wagging the tail?

ALEXANDRIA, Va. — The Senate Armed Services Subcommittee on Personnel on Wednesday held a hearing to discuss the fiscal year 2013 defense authorization.

In line with the hearing, the National Association of Chain Drug Stores submitted comments to the subcommittee — which has jurisdiction over all matters relating to active and reserve military personnel, including pay rates, military healthcare and education benefits, among others — regarding cuts to the Tricare program. The White House’s recent proposed fiscal year 2013 budget for the Department of Defense includes a host of changes that would prevent Tricare beneficiaries from obtaining many medications at their community pharmacy and increase cost sharing by as much as $34 for a 30-day supply of medications from a retail pharmacy, NACDS said.

"In addition to unfairly penalizing Tricare beneficiaries who prefer to use local pharmacies, NACDS believes this proposal is penny wise and pound foolish," NACDS said in the comments submitted for the hearing record. "Threatening beneficiary access to prescription medications and their preferred healthcare provider will only increase the use of more costly medical interventions, such as physician and emergency room visits and hospitalizations."

In its comments, NACDS also offered the following proposals:

The adoption of other policies to reduce costs without negatively affecting either pharmacy access or health outcomes. "The utilization of generic medications by Tricare beneficiaries is low in comparison with other plans. Modest increases in generic utilization by TRICARE beneficiaries would have a dramatic impact on the DoD budget," NACDS said;

NACDS also proposed that DoD conduct a demonstration project on the effectiveness of medication therapy management in reducing healthcare costs and improving medication adherence, or the proper use of medicine as prescribed by a physician; and

NACDS recommended the development of a "drug stock replacement" program for community pharmacies that could result in savings of up to 30%. This model, currently utilized by the Tricare mail-order pharmacy, would implement depot pricing for prescription drugs provided at retail pharmacies and would enable DoD to obtain more rebates from drug manufacturers. "NACDS believes using depot pricing for covered prescription drugs provided through the retail pharmacy network would assist DoD in negotiating additional discounts from drug manufacturers, beyond the federal ceiling price (FCP) discounts currently required by law."

"We look forward to working with you on policies that control costs and preserve access to local pharmacies," NACDS concluded.

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